Pro-symbioflor

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Pro-Symbioflor (PRO-SYMBIOFLOR®)

Composition:

Active substances: 1 ml of suspension contains: sterile bacterial lysate prepared from Escherichia coli bacteria 1.5–4.5 × 10⁷ bacteria, Enterococcus faecalis bacteria 1.5–4.5 × 10⁷ bacteria;

Excipients: lactose monohydrate; sodium carbonate decahydrate; sodium chloride; magnesium sulfate heptahydrate; potassium chloride; calcium chloride dihydrate; magnesium chloride hexahydrate; nutrient medium (casein peptone, yeast extract, sodium chloride, glucose monohydrate) and purified water.

1 ml of the preparation contains 14 drops.

Pharmaceutical form. Oral drops, suspension.

Main physicochemical characteristics: golden-yellow, slightly cloudy suspension, free from particles.

Pharmacotherapeutic group.

Other immunostimulants. ATC code L03AX.

Antidiarrheal microorganisms. ATC code A07FA.

Pharmacological properties.

Mechanism of action

Two bacterial species, Enterococcus faecalis and Escherichia coli, from which the active ingredient of the Pro-Symbiophlor preparation is derived, are part of the normal intestinal flora in humans. The active ingredient of Pro-Symbiophlor is a bacterial lysate obtained by disruption of these bacterial species.

Studies using human peripheral blood lymphocytes have shown that Pro-Symbiophlor exerts an immunomodulatory effect.

Clinical efficacy and safety

A placebo-controlled, randomized, double-blind clinical trial involving approximately 300 patients with irritable bowel syndrome demonstrated good or very good treatment success in 67.6% of patients treated with Pro-Symbiophlor, compared to 47.6% in the placebo group (p < 0.01).

The use of Pro-Symbiophlor in approximately 300 newborns (aged from 5 weeks to 7 months) at a dose of 10 drops three times daily for 6 months for the prevention of atopic dermatitis was found to be safe.

Clinical characteristics.

Indications.

Functional disorders of the gastrointestinal tract and irritable bowel syndrome.

Contraindications. Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction. Unknown.

Special precautions for use

Pro-Symbioflor does not contain stabilizers and is therefore susceptible to contamination if storage conditions are compromised. To avoid contamination, open the bottle only briefly and dispense the drops carefully so that drops fall one after another. Do not touch the dropper tip! To facilitate the release of drops, tap the bottle gently and hold it at an angle, especially at the beginning and end of use. The drop rate can be adjusted by changing the angle at which the bottle is held.

The product contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not use this product.

Before diagnosing irritable bowel syndrome, all possible organic causes of gastrointestinal disorders should be excluded.

Use during pregnancy or breastfeeding
The teratogenic effect of the product is unknown. During pregnancy or breastfeeding, it is recommended to use the product only after a physician has evaluated the benefit-risk ratio.

Ability to affect the speed of reactions when operating vehicles or other machinery
Pro-Symbioflor has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage.

Adults: At the beginning of treatment, take 5 drops 3 times a day for 2 weeks, gradually increasing by 2 drops every 2 days until reaching 20 drops 3 times a day. Maximum daily dose – 60 drops.

Children: The dose is determined individually by a physician. Usually, at the beginning of treatment, 5 drops per day should be taken, increasing over 2 weeks up to 10 drops 3 times a day.

If signs of meteorism, bloating, or discomfort in the upper abdomen occur at the beginning of treatment, the dose should be reduced or the increase in the number of drops should be slowed down.

Before use, shake the bottle vertically 5 times, resulting in a cloudy appearance. Dilute the single dose in 30 ml of water and take with food.

Duration of treatment – 8 weeks. If necessary, the treatment period may be extended after consultation with a physician.

Children. The drug is recommended for use in children aged 3 years and older.

Overdose. Not reported.

Side effects.

Infrequently (≥1/1000 to <1/100), symptoms of flatulence, bloating, and upper abdominal discomfort may occur. In such cases, it is recommended to reduce the dose or increase the number of drops more gradually.

Shelf life. 2 years.

After first opening the bottle – 4 weeks.

Storage conditions. Store the unopened bottle at a temperature not exceeding 30 °C. Do not freeze. Close the bottle tightly immediately after use and store in the refrigerator at 2 °C – 8 °C.

Keep out of reach of children.

Packaging. A cardboard box containing a 50 ml dropper bottle of the medication.

Availability. Over-the-counter (without prescription).

Manufacturer.

SymbioPharm GmbH.

Manufacturer's address and place of business.

Auf den Lüppen 10, 35745 Herborn, Germany.